NDC 76282-708

DIFLUPREDNATE

Difluprednate

DIFLUPREDNATE is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Exelan Pharmaceuticals, Inc.. The primary component is Difluprednate.

Product ID76282-708_8cddb271-2bf9-4493-b5cf-547f56c46caf
NDC76282-708
Product TypeHuman Prescription Drug
Proprietary NameDIFLUPREDNATE
Generic NameDifluprednate
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-12-10
Marketing CategoryANDA /
Application NumberANDA211776
Labeler NameExelan Pharmaceuticals, Inc.
Substance NameDIFLUPREDNATE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 76282-708-50

1 BOTTLE in 1 CARTON (76282-708-50) > 5 mL in 1 BOTTLE
Marketing Start Date2021-12-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "DIFLUPREDNATE" or generic name "Difluprednate"

NDCBrand NameGeneric Name
69097-341DIFLUPREDNATEDIFLUPREDNATE
69238-1380DifluprednateDifluprednate ophthalmic
76282-708DIFLUPREDNATEDIFLUPREDNATE
0078-0862DUREZOLdifluprednate

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